健仕平"山德士"40毫克/毫升注射劑

Nazione: Taiwan

Lingua: cinese

Fonte: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Principio attivo:

GEMCITABINE HYDROCHLORIDE

Commercializzato da:

台灣山德士藥業股份有限公司 臺北市中山區民生東路3段2號8樓 (90003886)

Codice ATC:

L01BC05

Forma farmaceutica:

注射劑

Composizione:

GEMCITABINE HYDROCHLORIDE (1010000610) (corresponding to 40mg Gemcitabine)MG

Confezione:

瓶裝;;盒裝

Classe:

製　劑

Tipo di ricetta:

限由醫師使用

Prodotto da:

FAREVA Unterach GmbH MONDSEESTRASSE 11, 4866 UNTERACH AM ATTERSEE, AUSTRIA AT

Area terapeutica:

gemcitabine

Indicazioni terapeutiche:

非小細胞肺癌、胰臟癌、膀胱癌。GEMCITABINE與PACLITAXEL併用，可使用於曾經使用過ANTHRACYCLINE之局部復發且無法手術切除或轉移性之乳癌病患。用於曾經使用含鉑類藥物(PLATINUM-BASED)治療後復發且間隔至少6個月之卵巢癌，作為第二線治療。膽道癌。

Dettagli prodotto:

有效日期: 2028/03/18; 英文品名: Gemcitabine Sandoz 40mg/ml Concentrate for Solution for Infusion

Data dell'autorizzazione:

2013-03-18

Foglio illustrativo

45.56gemcitabine hydrochlorider
40gemcitabine
5200gemcitabine (as hydrochloride)
251000gemcitabine (as hydrochloride)
502000gemcitabine (as hydrochloride)
(pH)
pH: 2.0-2.8
Gemcitabine
paclitaxel
anthracycline
(platinum-based)
6
● - Gemcitabine
Cisplatin
(IIIaIIIb)(IV )
Gemcitabine
●
- Gemcitabine
(
II
III
)
(
IV
)
Gemcitabine
5-FU
●
[
(TCC of the urothelium)] - Gemcitabine
Cisplatin
(
)(TCC of the urothelium)
● - Gemcitabine
paclitaxel
anthracycline
anthracycline
● - (platinum-based)
6
●
- Gemcitabine
(
)
Gemcitabine
1000 mg/m
2
21
1
8
gemcitabine 30
GemcitabineCarboplatin AUC 4Carboplatin
-
Gemcitabine
((7))
(5)
4
Gemcitabine
1000 mg/m
2
1
8
15
30
Gemcitabine
cisplatin
1
Gemcitabine
cisplatin 100 mg/m
2
3
Gemcitabine
1250 mg/m
2
1
8
30
Gemcitabine
cisplatin
1
cisplatin 100 mg/m
2
-
(
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(5)
Gemcitabine
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GEMCITABINE SANDOZ 40MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Gemcitabine1250 mg/m
2
2118gemcitabine30
Paclitaxel
Gemcitabine
Paclitaxel 175 mg/m
2
3
-
gemcitabine
((7))
(5)
gemcitabine
1
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(x10
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/L)
1500
<1500
1500
1000-1499
<1000
(x10
6
/L)
100,000
<100,000
100,000
75,000-99,999
<75,000
100%
100%
50%
gemcitabine
1
8
(x10
6
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1500
<1500
1200
1000-1199
700-999
<1000
(x10
6
/L)
100,000
<100,000
75,000
75,000-99,999
50,000
<50,000
100%
100%
75%
50%
gemcitabine
(x10
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/L)
1000
500-999
<500
(x10
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100,000
50,000-99,999
<50,000
(%)
100%
75%
gemcitabine
1, 8800 mg/m
2
gemcitabine800 mg/m
2
1
● <500 x 10
6
/L 5
● <100 x 10
6
/L 3
●
● <25,000 x 10
6
/L
●
Gemcitabine
cisplatin
cisplatin
(≥5% ()≥2% (34))
a
C
c
e
Alkaline Phosphatase
Creatinine
f
Neuro motor
Neuro sensory
Neuro cortical
Neuro mood
89
39
79
85
21
75
22
19
23
15
38
30
30
18
93
78
53
35
24
23
18
16
16
16
15
14
14
14
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22
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12
0
0
2
0
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0
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0
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0
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cisplatin
b
67
13
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13
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31
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7
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